摘要
目的探讨艾普拉唑肠溶片对十二指肠球部溃疡患者胃内pH的影响，初步评价其抑酸作用。方法采用多中心随机、对照、双盲设计。42例入选者随机分入艾普拉唑5mg组（5mg／a）、10mg组（10mg／d）、20mg组（20mg／d）和奥美拉唑20mg组（20mg／d）。于服药第5天进行胃内pH监测。比较各组间胃内pH≥3、≥4、≥5的时间百分比、24h的pH中位数、夜间12h的pH中位数及pH≥3、≥4、≥5至少维持18h的患者百分比。结果各组间pH≥3、≥4的时间百分比的差异没有统计学意义（P〉0．05），pH≥5的时间百分比在艾普拉唑10mg组和20mg组分别为（87．96±12．29）％和（89．86±15．18）％，高于艾普拉唑5mg组的（67．17±30．16）％和奥美拉唑20mg组的（76．14±16．75）％，P〈0．05。各组间24h的pH中位数和夜间12h的pH中位数的差异没有统计学意义，pH≥3、I〉4、≥5至少维持18h的患者百分率在各组间的差异没有统计学意义。结论新型质子泵抑制剂艾普拉唑的抑酸作用强，抑酸作用随剂量增加呈递增趋势。
Objective To evaluate the effect of ilaprazole enteric tablets on intragastric pH in duodenal ulcer patients. Methods A randomized, double blind, positive controlled clinical trial was carried out. A total of forty-two patients with duodenal ulcer were randomized into low dose ilaprazole group （5 mg/d）, medium dose ilaprazole group （10 rag/d）, high dose ilaprazole group （20 mg/d） and omeprazole group （20 mg/d）. An ambulatory 24 hour intragastric pH study was performed at the fifth treatment day. Fraction time pH above 3, 4 or 5, median values of 24 hour diurnal pH and 12 hour nocturnal pH, the percentage of patients with total time pH above 3, 4 or 5 at least for 18 hours were evaluated. Results There were no significant differences of fraction time pH above 3 or 4, median values of 24 hour diurnal pH and 12 hour nocturnal pH and the percentage of patients with total time pH above 3, 4 or 5 at least for 18 hours among all the groups with different doses of ilaprazole and the omeprazole group. The fraction time pH above 5 in medium and high dose ilaprazole groups were （87.96 ± 12.29 ）% and （89. 86± 15.18）% respectively, which was higher than that in low dose ilaprazole group [ （67. 17 ± 30. 16） % ] and omeprazole group [ （76. 14 ± 16. 75 ） % ], P 〈 0.05. Conclusion Ilaprazole has a strong effect on intragastrie acid control with a dose dependent trend.
出处
《中华内科杂志》
CAS
CSCD
北大核心
2010年第4期290-292,共3页
Chinese Journal of Internal Medicine
